How do you ensure the traceability of the batch documentation?
To ensure the traceability of the batch documentation,
• make sure independent verification of traceability, e.g. in the context of self-inspections.
• check consistency with other documents, including process validation, validation of holding times, media fills, clean and dirty hold times.
• in particular, ensure the traceability of the chronological order and reconciliation.
[GMP Compliance Adviser, Chapter 21.C]
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